Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
Adverse-event figures are drawn from the U.S. Food & Drug Administration (FDA) MAUDE database, refreshed March 2026, see our methodology.
OpenFDA device adverse-event casebook.
FDA Class II (moderate risk, special controls required), regulated under 21 CFR §888.3530 (Orthopedic panel).
FDA MAUDE casebook
openFDA event book Prosthesis LIGHT-BOOK · MAUDE
#222 of 1000 · 9,644 reports · 1991–2026
- BOOK 9,644 reports
- RANK #222 of 1000
- DEATH 9 death-typed
- INJ 6,325 injury-typed
- MALF 3,199 malfunction
- SPAN 1991–2026
- PEAK 2021: 1,218
- PHOTO Ring, Annuloplasty
Nearest event-volume peer: Ring, Annuloplasty (29 report gap)
Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer sits #222 of 1000 among tracked device types with 9,644 MAUDE reports spanning 1991–2026. Rank counts report volume, not confirmed device fault. Event_type Death / Injury / Malfunction are one code per report — not the same population as patient-outcome rows ( methodology). Read with this device → · Lead manufacturer → · Similar-volume device →
Injury-coded reports run above the device-type norm
Prosthesis carries 65.6% INJURY-coded reports, 35.3pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.
- DEATH 0.1% corpus 1.5% · below corpus mean (-1.4 pp)
- INJ 65.6% corpus 30.3% · above corpus mean (+35.3 pp)
- MALF 33.2% corpus 64.8% · below corpus mean (-31.7 pp)
Lead product-problem code Break is 16% of coded problems · Lead manufacturer SMITH & NEPHEW, INC. accounts for 42% of manufacturer-tagged reports · Top event location is 45% of location-tagged rows .
Prosthesis in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Appliance
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
9,903 reports
- Driver
Driver, Prosthesis
9,682 reports
- Ring
Ring, Annuloplasty
9,673 reports
- Prosthesis (this)
Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
9,644 reports
- Motor
Motor, Drill, Pneumatic
9,613 reports
- Keratome
Keratome, Ac-Powered
9,578 reports
What this shows Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer carries 9,644 MAUDE reports, ranked #222 of 1000.
Event Types
Patient Outcomes
FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.
Top Product Problems
Yearly Trend
Reports in 2025 (301) held close to the prior two-year average of 413.
Related Entities for Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
Top Manufacturers
Event Locations
Nationwide devices with a comparable volume-and-death footprint
Two openFDA-derived peer sets for Prosthesis: nearest by total report volume and nearest by death-typed count, each floored at ≥100 reports so the neighborhoods stay in the advertised mass.
Similar report volume
Nearest other device types by FDA MAUDE report count (9,644 here).
Similar death-typed counts
Nearest other device types by death-typed report count (9 here), distinct from the volume row.
Read our methodology - how this data is sourced, computed, and verified.
Disclaimer: MAUDE figures for Prosthesis are informational only and are not clinical advice. Report codes do not prove device causation. Consult a qualified clinician before acting on this data.
Every figure on PlainHospital is rendered directly from federal source data, no number is typed in by an editor. Event-type mix on this page is computed from FDA MAUDE codes for Prosthesis; corpus means use device types with ≥100 reports. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of August 2026.